Recall Z-1782-2017— Ge Medical Systems Information T
Class II · Terminated
Class II FDA medical device recall by Ge Medical Systems Information T, initiated 2013-02-18, terminated 2017-07-31. It names one FDA 510(k) clearance: K083018. Product: Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.. Reason: It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder..
- Recalling firm
- Ge Medical Systems Information T
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-18
- Terminated
- 2017-07-31
- Firm location
- Barrington, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
Reason for recall
It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
Data sourced from openFDA. This site is unofficial and independent of the FDA.